The Year Ahead in US Medtech: An Interview with Mark Leahey

As we look ahead at the issues likely to confront the device industry in 2024, we turn once again to what has become a regular feature in Market Pathways, which is an opportunity to sit down with Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA) trade association. Few industry observers combine the experience and perspective that he provides in his position at the intersection of industry and government regulators and legislators.

Perhaps most prominent among the issues discussed in this interview is one of the more recent acronyms to emerge as part of the medtech lexicon: TCET (Transitional Coverage for Emerging Technologies). Recall that TCET has superseded MCIT (Medicare Coverage of Innovative Technologies), a short-lived experiment that after languishing since the Obama administration was surprisingly resurrected in the latter days of the Trump administration, only to be quickly repealed by President Biden.

Here, Mark Leahey addresses the proposal that CMS put forth in June to create a streamlined framework for national coverage of new devices that didn’t go as far as many device policy advocates and industry executives had hoped, leaving the industry waiting for the final guidance. In a nutshell, rather than establishing a new coverage pathway, CMS stayed well within the bounds of the current National Coverage Determination/Coverage with Evidence Development (NCD/CED) framework. The agency proposed front-loading its NCD application process for select FDA Breakthrough Devices to accelerate data review and generate “fit-for-purpose” evidence development plans prior to FDA authorization, with a goal of issuing a final coverage policy within six months of regulatory approval. (See “TCET Proposal Has Merit But Doesn’t Meet the Moment, Execs Say,” Market Pathways, August 1, 2023.)

Another important issue facing the industry and regulators this year is the need to resolve the discord surrounding potential restrictions on the use of ethylene oxide (EtO) for medical device sterilization. Not only is there a conflict between industry and the federal government—with, in this case, EPA being the relevant agency—but also different arms of the administration are potentially coming down on opposite sides of this question, adding to the complexity of solving a problem that might otherwise result in product companies having to move sterilization efforts offshore, a process that will only increase the time and cost of delivering innovative devices.

With no shortage of challenges facing the industry in the coming year, Leahey observes that the atmosphere of increased transparency, responsiveness, and consistency that has characterized Jeff Shuren’s tenure running FDA’s device center for just over a decade, resulting in improved relations between the industry and regulators, continues to flourish and is likely to remain the defining tenor in the year ahead. It is worth noting that this is in stark contrast to the situation in Europe, where the regulatory landscape remains muddled with added cost and complexity under MDR/IVDR with no signs of short-term relief. Leahey’s optimism about the continued climate at FDA, in the face of the significant challenges facing industry as outlined in the interview, allows us to end on an always welcome encouraging note. (This interview has been edited for length and clarity.)